Gilead Clinical Trial FAQs

Interventions can include drugs, vaccines, medical devices, medical procedures and behavioral interventions.

Before a new medical intervention can be approved for use, it must be shown to be safe and effective. Clinical trials are a critical part of this process.

Each clinical trial has a specific “protocol” that describes how it will study the intervention, including how participants will be divided into groups, required site visits and the health outcomes being measured. For instance, participants may be randomly assigned to the experimental intervention, the current standard intervention or a placebo. The comparison of data from each group is how safety and effectiveness are measured.

Volunteers who match study requirements, such as gender, age, condition, or treatment history, can join a clinical trial. A member of the research team will screen all volunteers to confirm they meet the requirements of the trial.

No, you are welcome to inquire about participating in any ongoing study directly.

All trials have different timelines due to various factors, such as the trial phase, study design, treatment duration or health condition being studied. During the consent process before enrolling, the research team will explain the specifics about the trial.

Trial sites include hospitals and medical centers, universities and doctors’ offices. Some trials have more than one study location, but each has a full research team.

Children are eligible for trials that have been designed specifically for them. For greater protection, regulations and ethical standards for these studies are more rigid. Since children’s bodies are still developing, they can react differently to interventions and it is important to study and understand the differences. In addition, there are many conditions that only affect children. They will need to have a parent or legal guardian who signs the consent forms and oversees whether a child should continue to participate in the study.

If you are living with a medical condition, joining a clinical trial may give you access to a new potential treatment before it is publicly available. Just as importantly, it can help researchers understand how this potential treatment affects the body and increase their knowledge about the disease and how to treat it. Participation can also play a vital role in helping others who have a similar condition, both now and in the future. Healthy volunteers in trials contribute to this medical progress as well by helping understand the effect of the potential treatment and any safety concerns.

There may be some potential and real risks in participation. The experimental intervention might be less effective than current, standard interventions if available for the indication being studied. You could experience side effects. However, precautions are built into the study design to help ensure the safety of participants as much as possible. Many clinical trials have a Data Safety Monitoring Board (DSMB), a group of experts that is separate from the company and researchers running the trial who regularly reviews trial data. The DSMB has the ability to end the trial if the intervention being studied is found to be unsafe or far less effective than the standard of care or placebo. You may always withdraw from the trial at any time if desired.

Not all trials pay participants, but some do receive modest compensation for reimbursement for travel, and study-related time and commitment. The amount varies. The research team will provide you these details if they apply.

Due to the many differences in insurance plans across the country, coverage in clinical trials can vary. You will learn more about your options during pre-screening.

As with all medical records, participant privacy and confidentiality in trials are protected by law. Once consent is signed, you will be given a trial code. Your trial records will not include your name or personal identity but will identify you with a trial code. This code can only be tracked back to you via a code key which is held by the responsible physician. Your name or personal identity will never be disclosed.

Yes, participants are volunteers and may withdraw from a clinical trial at any time.

Regulatory agencies have strict guidelines that research teams must follow to ensure all patients are treated fairly and safely, and that the trial's potential benefits outweigh risks. Each trial has a "protocol" that includes necessary protections, and an Institutional Review Board/Ethics Committee (IRB/EC) that reviews the data and can end the trial at any time.

During any trial, side effects may occur and identifying them is an important part of the intervention approval process. Any known side effects are outlined in the Informed Consent Form (ICF), which participants will read and review with a healthcare provider during the pre-screening and consent process, but there may also be unknown risks. Your research team will closely monitor any side effects and you always have the option to withdraw from the trial at any time.

Your informed consent is required before being enrolled in a trial. This means you have been provided all relevant information about the study design, how you will participate, your right to withdraw at any time, study alternatives, your personal data protection and the associated risks and benefits. Informed consent is designed to protect patient safety and privacy.

"Standard of care" is an intervention already approved for a specific health condition that is available publicly. Interventions in a clinical trial are still being tested to ensure safety and effectiveness.

To ensure quality data and no bias when comparisons need to be made between treatment groups, each participant is randomly assigned to the different groups (i.e., experimental intervention, standard intervention, or placebo). Think about a coin toss: Just as it is unknown whether you will turn up heads or tails, it is unknown whether you will receive an intervention or a placebo.

A placebo is an inactive version of an intervention that is not intended to provide any medical benefit. It is designed to look the same as the active intervention, so the participant and research team do not know it is a placebo. The placebo is used by comparison to confirm any effects of the intervention being studied, if no approved intervention is available.

Some clinical trials are designed to be "double blind" so both participants and researchers are unaware of which treatment group participants are assigned to. This prevents bias from affecting clinical trial data.

Researchers must compare the effects of a new intervention on participants to those who do not receive the intervention. They are called the “control” or “control group,” and they may receive either a placebo or nothing at all.

Under FDA regulations, an Institutional Review Board (IRB) is a group that has been formally designated to review and monitor research at a hospital or institution involving human participants. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in, or disapprove research.

Under European Medicines Agency (EMA) regulations, an Ethics Committee (EC) reviews research proposals at a healthcare facility involving human participants and their data to ensure that they agree with local and international ethical guidelines. ECs have the authority to approve, reject, modify or stop studies that do not conform to the accepted standards.

A DSMB is a group of qualified individuals that monitors the clinical study to ensure the safety of study participants, as well as the validity and integrity of the study data.

Patients with an immediately life-threatening condition can potentially gain access to an experimental intervention when there are no other adequate options available. This type of clinical trial is different from the normal types of trials because it offers people access to a study drug even if they can’t participate in a clinical trial.

Before you join a clinical trial, read everything you can about the condition and treatment. If interested, you can discuss it with your usual healthcare provider or reach out directly to the clinical research team. Bring whatever remaining questions you have to the research team during your screening. Important considerations include benefits and risks, what you will have to do during the trial and the requested time commitment.

There are a wide variety of professionals involved with any clinical trial, all of whom are vital to ensuring safety and success. The principal investigator, or PI, leads the trial and directs the team of doctors, nurses and other healthcare workers. The clinical trial coordinator manages day-to-day activities and is the main contact for participants. Many clinical trials also have an independent Data and Safety Monitoring Board (DSMB) who periodically reviews data to ensure participant safety, and sometimes effectiveness.

For the best possible clinical trial results, participants should attend each scheduled trial visit. If you have a conflict, please contact your research team in advance to adjust your schedule.

Participants are always welcome to visit their usual healthcare providers during a trial. Sometimes, it is important for healthcare providers to collaborate with the research team to ensure success.

When you reach the end of your participation in the trial, you may meet with your regular healthcare provider to determine further care options. If you are a healthy volunteer, your commitment is over. Keep in mind that researchers can decide to end trials earlier than expected.

After your participation ends, the study may continue for months or years. Once final results from all participants are compiled and analyzed, they are often published publicly. Clinical study report (CSR) synopses and plain language summaries (PLSs) may be made available for certain studies. Check with your clinical trial site or send an email to [email protected] to learn more.

If you don’t qualify because you don’t meet the trial criteria, consider discussing other options with your healthcare provider or the patient’s physician would need to submit a managed access request based on the eligibility. Click here to learn more.